SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

GISH TUBING AND CONNECTORS WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBS REVOLUTION

FDA 510(k)

FDA Class 2 ·Radiology

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GAS-VAK(R), MODEL 300

FDA 510(k)

FDA Class 2 ·Anesthesiology

GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

MEDICAL LASER MIXTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUNG DIFFUSION

FDA 510(k)

FDA Class 2 ·Anesthesiology

LASER GAS MIXTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HELONTIX VENT

FDA 510(k)

FDA Class 2 ·Anesthesiology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology